FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

681 results for "regulatory technology services, llc"
433–456 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 17, 2014
NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
K133833 · IYN
Philips Ultrasound, Inc.
Radiology · 31d
Cleared Dec 27, 2013
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K133505 · IYN
Samsung Medison Co., Ltd.
Radiology · 43d
Cleared Dec 17, 2013
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP...
K132340 · FEQ
Erbe USA, Inc.
Gastroenterology & Urology · 144d
Cleared Nov 27, 2013
UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
K133329 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Nov 19, 2013
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
K132779 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 75d
Cleared Oct 04, 2013
UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM
K132861 · IYN
Samsung Medison Co., Ltd.
Radiology · 22d
Cleared Sep 26, 2013
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
K132777 · LIT
Ev3, Inc.
Cardiovascular · 21d
Cleared Aug 29, 2013
MZ1000
K132413 · FPA
Care Fusion
General Hospital · 27d
Cleared Aug 21, 2013
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
K132304 · IYN
Philips Ultrasound, Inc.
Radiology · 28d
Cleared Aug 20, 2013
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM
K132228 · IYO
Samsung Medison Co., Ltd.
Radiology · 34d
Cleared Aug 15, 2013
DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
K132341 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 20d
Cleared Aug 09, 2013
QLAB QUANTIFICATION SOFTWARE
K132165 · LLZ
Philips Ultrasound, Inc.
Radiology · 28d
Cleared Aug 02, 2013
SIDEKICK AND USHER SUPPORT CATHETERS
K131493 · DQY
C.R. Bard, Inc.
Cardiovascular · 71d
Cleared Jul 23, 2013
ESIE APPS SUITE
K132062 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Jul 23, 2013
ULTRAEXTEND USWS-900A V2.1 AND V3.1
K131822 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 33d
Cleared Jun 11, 2013
NON-PYROGENIC ULTRASOUND TRANSDUCER COVER
K131528 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 14d
Cleared May 30, 2013
ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
K131199 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 34d
Cleared May 24, 2013
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
K130911 · LIT
Ev3, Inc.
Cardiovascular · 52d
Cleared Apr 12, 2013
UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM
K130803 · IYN
Samsung Medison Co., Ltd.
Radiology · 21d
Cleared Mar 25, 2013
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K130754 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 6d
Cleared Mar 21, 2013
ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM
K130619 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Feb 12, 2013
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
K123544 · LIT
Ev3, Inc.
Cardiovascular · 85d
Cleared Jan 23, 2013
FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)
K123310 · GEI
Utah Medical Products, Inc.
General & Plastic Surgery · 90d
Cleared Dec 21, 2012
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
K123754 · IYN
Philips Ultrasound, Inc.
Radiology · 15d